NCT02467049

Brief Summary

In the prevention of thrombosis related to catheter placement it is important to have a right position of the catheter tip. Therefor we want to assess which technique is the most successful in the placing of a PICC.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
10

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jun 2015

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 26, 2015

Completed
6 days until next milestone

Study Start

First participant enrolled

June 1, 2015

Completed
8 days until next milestone

First Posted

Study publicly available on registry

June 9, 2015

Completed
2.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2017

Completed
Last Updated

April 17, 2019

Status Verified

April 1, 2019

Enrollment Period

2.4 years

First QC Date

May 26, 2015

Last Update Submit

April 16, 2019

Conditions

Keywords

ECGUltrasoundPeripherally Inserted Central CathetersPICC

Outcome Measures

Primary Outcomes (1)

  • Number of participants with correct placement in the superior caval vein during PICC insertion, after either ECG or ultrasound guided insertion

    The aim of the study is a comparison between two techniques to control correct positioning of the PICC

    Whitin 5 minutes after catheter-placement

Secondary Outcomes (2)

  • Duration of PICC-placement by ECG-guidance versus ultrasound-guidance

    within 5 minutes

  • frequency of necessity of replacement after chest-x-ray control

    1 day

Study Arms (2)

ECG-guided insertion of PICC

ACTIVE COMPARATOR

Placement of the PICC (Peripherally Inserted Central Catheter ) ECG-guided insertion.

Device: ECG-guided insertion of PICCDevice: ULTRASOUND-guided insertion of PICC

ULTRASOUND-guided insertion of PICC

EXPERIMENTAL

Placement of the PICC (Peripherally Inserted Central Catheter ) ULTRASOUND-guided.

Device: ECG-guided insertion of PICCDevice: ULTRASOUND-guided insertion of PICC

Interventions

Comparison of placement of a PICC (Peripherally Inserted Central Catheter) by ECG-guidance vs. ULTRASOUND-guidance

ECG-guided insertion of PICCULTRASOUND-guided insertion of PICC

Comparison of placement of a PICC (Peripherally Inserted Central Catheter) by ECG-guidance vs. ULTRASOUND-guidance

ECG-guided insertion of PICCULTRASOUND-guided insertion of PICC

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • All adults with indication for PICC

You may not qualify if:

  • Age \<18y
  • Pregnant women

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Universitair Ziekenhuis Brussel

Jette, Brussels Capital, 1090, Belgium

Location

MeSH Terms

Conditions

InfectionsNeoplasmsMalnutrition

Condition Hierarchy (Ancestors)

Nutrition DisordersNutritional and Metabolic Diseases

Study Officials

  • Lucie Choustoulakis, MD

    Department of Anaestesiology and Perioperative Medicine Acute and Chronic Pain Therapy.

    PRINCIPAL INVESTIGATOR
  • Jan Poelaert, MD, PhD

    Department of Anaestesiology and Perioperative Medicine Acute and Chronic Pain Therapy.

    STUDY CHAIR
  • Matthias Raes, MD

    Department of Anaestesiology and Perioperative Medicine Acute and Chronic Pain Therapy.

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Study Nurse

Study Record Dates

First Submitted

May 26, 2015

First Posted

June 9, 2015

Study Start

June 1, 2015

Primary Completion

November 1, 2017

Study Completion

November 1, 2017

Last Updated

April 17, 2019

Record last verified: 2019-04

Data Sharing

IPD Sharing
Will not share

Locations